Requirements for Site Governance Submission

There are a number of processes in place to ensure that ACT Health meets all of its legal and regulatory requirements. These steps are important to protect participants, staff, researchers and the institution.

Every research study must have appropriate ethics approval prior to being granted governance authorisation. See the section on requirements for ethics submission for more information.

All clinical trials must seek in principle support from the Clinical Trials Committee (CTC) prior to submitting for ethical approval or, in the case of NMA exempted studies, site specific governance approval. For more information, please see the Clinical Trials section.

Cover Page
A Cover page is required for all ethical and site governance review applications.

Human Research Application Form (HREA)
An electronic application for signed by ACT-based researchers must be provided. The may be provided within the REGIS platform or through the online forms website.

Protocol or Research Plan
The ACT Health HREC will not accept submissions without a protocol or research plan. Example protocol templates are provided, however these may be varied as required:

Site PICF Checklist
A Site PICF checklist is required for all applications that include participant recruitment.

Current CV for each investigator
An updated CV for each investigator is required for both ethical and site governance applications.

Evidence of current Good Clinical Practice (GCP) training for each investigator
This is required all clinical applications. Each investigator and research team member must provide evidence of GCP training for both ethical and site governance applications. A free online GCP training course can be found through the Global Health Training Centre.

Research involving ionising radiation
All research that involves ionising radiation must be appropriately documented. Where ionising radiation exposure in a research project is not considered to be additional to standard of care for clinical management/care of the patient group at the site use this form (Ionising Radiation Exposure Statement). Where radiation exposure is additional to standard of care a full report from an approved Medical Physicist is required to be submitted to the reviewing HREC and/or site governance office. The Medical Physicist must be approved in the state/territory in which the site is located.

The following are additional documentation requirements for applications which include an agreement or contract with ACT Health.

10. Clinical Trial Agreement or other applicable agreements
This must be the final version with approved budget.

11. Signed Medicines Australia Standard Form of Indemnity (if applicable)
This must be signed by the sponsor.

12. Current Insurance Certificate (if applicable)
See the Insurance dropdown for requirements. Please Note: HREC approval should be taken to include ACTIA insurance approval. A separate site governance sheet will be provided by the secretariat office. Please direct queries to research.governance@act.gov.au or 02 5124 7968.

Insurance Requirements for Sponsored Clinical Trials

The insurance certificate must specifically name the Australian Corporate entity acting as commercial sponsor as a named insured under the relevant insurance policy

If the certificate is provided in the name of an overseas parent company, it must name the Australian entity as a subsidiary

The insurance certificate must include a valid coverage period for the policy

The insurer providing the cover must be approved by the Australian Prudential Regulation Authority and must have a minimum financial strength rating of A- or above

The insurance certificate must provide coverage of AUD$20 million for each and every occurrence and AUD$20 million in the annual aggregate against a class of insurance appropriate for the risk associated with the research.